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510(k) Data Aggregation

    K Number
    K022417
    Device Name
    CARE STIM
    Manufacturer
    CARE REHAB AND ORTHOPAEDIC
    Date Cleared
    2003-04-10

    (260 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Classic Stim is recommended for use for the following conditions:
    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education
    • Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
    • Maintaining or increasing range of motion

    Device Description

    A portable NMS device for muscle re-education.

    AI/ML Overview

    This document describes the 510(k) summary for the CARE STIM™ muscle stimulator, and it declares non-clinical testing was sufficient to show substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from predicate)Reported Device Performance (CARE STIM™)
    Output characteristics of the predicate device (Ortho Dx muscle stimulator).Output characteristics are substantially equivalent.
    Intended Use of the predicate device.Intended Use is substantially equivalent.
    Labeling of the predicate device.Labeling is substantially equivalent.
    No new questions of safety and effectiveness compared to the predicate device.No new questions of safety and effectiveness are posed.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not applicable. The study relies on bench testing comparisons to a predicate device, not a human test set.
    • Data Provenance: Bench testing data comparing the output characteristics of the CARE STIM™ to the Ortho Dx. The country of origin and whether it's retrospective or prospective are not specified, but it would inherently be a prospective bench test.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Not applicable. Ground truth for device characteristics was established via engineering bench testing, not expert clinical assessment.

    4. Adjudication Method for the Test Set

    • Not applicable. This was a technical comparison, not a clinical study requiring adjudication of expert opinions.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    • Not applicable. This device is a muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was conducted.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not applicable. This is a physical medical device, not an algorithm. Bench testing was done on the device's electrical output.

    7. The Type of Ground Truth Used

    • Bench Test Comparison Records: The "ground truth" for the CARE STIM™ was the established output characteristics, intended use, and labeling of the predicate device (Ortho Dx). This was determined through non-clinical (bench) testing.

    8. The Sample Size for the Training Set

    • Not applicable. This is not a machine learning device and therefore does not have a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. No training set was used.
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